Robert L Ferris, Hisham Mehanna, Jonathan D Schoenfeld, Makoto Tahara, Sue S Yom, Robert Haddad, André König, Pauline Witzler, Marcis Bajars, Christophe Le Tourneau
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引用次数: 0
摘要
对于切除的、高风险、不符合顺铂治疗条件的局部晚期头颈部鳞状细胞癌（LA SCCHN）患者，目前尚有大量治疗需求未得到满足，也缺乏治疗方案。Xevinapant是第一类强效口服小分子IAP抑制剂，在临床和临床前研究中被认为能恢复癌细胞对化疗和放疗的敏感性。我们介绍了 XRay Vision（NCT05386550）的设计，这是一项国际性随机双盲 III 期研究。约 700 名切除、高危、不符合顺铂治疗条件的 LA SCCHN 患者将按 1:1 的比例随机接受 6 个周期的西维那潘或安慰剂治疗，前 3 个周期联合放疗。主要终点是无病生存期，次要终点包括总生存期、与健康相关的生活质量和安全性。
Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design.
There is a significant unmet need and lack of treatment options for patients with resected, high-risk, cisplatin-ineligible locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Xevinapant, a first-in-class, potent, oral, small-molecule IAP inhibitor, is thought to restore cancer cell sensitivity to chemotherapy and radiotherapy in clinical and preclinical studies. We describe the design of XRay Vision (NCT05386550), an international, randomized, double-blind, phase III study. Approximately 700 patients with resected, high-risk, cisplatin-ineligible LA SCCHN will be randomized 1:1 to receive 6 cycles of xevinapant or placebo, in combination with radiotherapy for the first 3 cycles. The primary end point is disease-free survival, and secondary end points include overall survival, health-related quality of life, and safety.
期刊介绍：
Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community.
The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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